PhRMA Principles on Conduct of Clinical Trials
To help assure that clinical research conducted by America’s biopharmaceutical companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients.
Developing new therapies to treat disease and to improve quality of life is a long and complex process. A critical part of that process is clinical research, the study of a pharmaceutical product in humans. Without clinical research studies, no new medicines could be made available to patients. In sponsoring and conducting clinical research, PhRMA members place great importance on respecting and protecting the safety of research participants. Principles for the conduct of clinical research are set forth in internationally recognized documents, such as the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization. The principles of these and similar reference standards are translated into legal requirements through laws and regulations enforced by national authorities, such as the Food and Drug Administration. PhRMA members have had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. Many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.
Reference of the resource
Principles on Conduct of Clinical Trials, Codes & Guidelines, PhRMA Foundation.